Lower Dose Depo Provera® Contraceptive Injection

FHI 360

Status and phase: Completed; Phase 1

Conditions: Contraception

Treatments: Drug: Depo-subQ 104; Drug: Depo-Provera CI

Study type: Interventional

Funder types: Other

Identifiers

NCT02732418

834119

Details and patient eligibility

About

This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle

Full description

This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle. Baseline ovulation will be confirmed in all women by measuring serum progesterone (P) approximately twice a week during the 2-3 weeks preceding expected menses. Between 48 and 60 participants (12-15 per group) with confirmed ovulation who meet other eligibility criteria will be enrolled and randomized to receive a single SC injection in the abdomen of 1 of 3 doses of Depo-Provera CI: 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL or a single dose of Depo-subQ Provera (104 mg/0.65mL). Participants will be followed for 32 weeks (7.5 months) after the injection During the study participants will provide blood samples for MPA, P and estradiol (E2) prior to injection and then frequently at predefined time points through 7.5 months. In addition, for more accurate ascertainment of the PD response we will perform transvaginal ultrasound (TVS) and assess cervical mucus at predefined time points through 7.5 months. Information on adverse events and concomitant medications will be collected throughout the study. Information on acceptability will be collected at predefined time points through 7.5 months.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• has typical menstrual cycle of 24 to 35 days
• has confirmed ovulatory cycle during the pretreatment phase (serum progesterone ≥ 4.7 ng/mL in 2 consecutive samples)
• is sterilized or using non hormonal intrauterine device (IUD)
• is in good general health as determined by a medical history and physical examination
• 18 to 40 years of age (inclusive)
• willing to provide informed consent and follow all study requirements
• has negative urine pregnancy test and has no desire to become pregnant in the subsequent 12 months
• has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
• has hemoglobin ≥10.5 g/dL

Exclusion criteria

• has medical contraindications to depot medroxyprogesterone acetate (DMPA) [16]

• has undiagnosed mass in breast

• used DMPA in the past 12 months

• used a combined injectable contraceptive in the past 6 months

• used any of the following medications within 1 month prior to enrollment:

  • any investigational drug
  • prohibited drugs per protocol
  • oral contraceptives
  • Nuva-ring
  • contraceptive patch
  • levonorgestrel intrauterine system (LNG IUS) or contraceptive implant

• has been pregnant within last 3 months

• Is currently lactating

• in the opinion of the investigator, is potentially at elevated risk of HIV infection (HIV-positive partner, IV drug use by self or by partner)

• has more than one male sexual partner

• is using or plans to use prohibited drugs per protocol in the next 9 months

• has known sensitivity to MPA

• plans to move to another location in the next 9 months

• has any condition (social or medical), which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements or complicate data interpretation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

Depo-Provera CI 45 mg

Experimental group

Description:

a single subcutaneous (SC) injection of 45 mg/0.3 mL

Treatment:

Drug: Depo-Provera CI

Depo-Provera CI 75 mg

Experimental group

Description:

a single subcutaneous (SC) injection of 75 mg/0.5 mL

Treatment:

Drug: Depo-Provera CI

Depo-Provera CI 105 mg

Experimental group

Description:

a single subcutaneous (SC) injection of 105 mg/0.7 mL

Treatment:

Drug: Depo-Provera CI

Depo-subQ 104

Active Comparator group

Description:

a single subcutaneous (SC) injection of 104 mg/0.65 mL

Treatment:

Drug: Depo-subQ 104